Modification of Tsrh Spinal System

• • Terminated Z-3044-2011 FDA Unclassified (pre-2012) ·initiated 12 Jul 2011 ·on shared 510(k) K984522

  Screws are 5 mm longer than the size etched on the screw.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K984522 ↗

FDA Product Code

MNI

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Overhead Arm Slings

  Class I

  FDA 510(k) K823811 Active Cleared 14 Jan 1983

• Cd Horizon Spinal System

  Class II

  FDA 510(k) K993810 Active Cleared 3 Feb 2000

• Danek Precision Rod Set

  Class II

  FDA 510(k) K896254 Active Cleared 14 Jun 1990

• Spine Fixation

  Class II

  FDA 510(k) K943827 Active Cleared 14 Feb 1996

• Modification of the Zplate-Atl Anterior Fixation System

  Class II

  FDA 510(k) K990603 Active Cleared 10 Mar 1999

• Danek Spinalscope

  Class II

  FDA 510(k) K901692 Active Cleared 14 Feb 1992

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